Abdomenal Wound TraumaNCT03431220
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
A study testing RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device in people with Abdomenal Wound Trauma, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomenal Wound Trauma
- What is being tested?
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
- Subjects must be at least eighteen (18) yeaTS of age, or older.
- Males and non-pregnant females.
- Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).
Who cannot join
- Grade 3 and Grade 4 open abdomens.
- Malignancy in the reference wound bed or margins of the wound.
- Patients with non-enteric unexplored fistulas.
- High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
- Pre-existing large ventral hernia.
- Significant loss of abdominal wall fascia as a result of trauma or infection.
- Patients with a known hist01y of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
- Conditions
- Abdomenal Wound Trauma
- Being tested
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) DeviceDevice
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| RENASYS TOUCH NPWT System | Experimental | Negative Pressure Wound Therapy (NPWT) Receives: Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the number of days taken to achieve delayed primary fascial closure.
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
Measured: 14 days
Secondary outcomes (12)
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
Measured: 14 days
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
Measured: 14 days
To confirm the performance of the NPWT system in terms of reduction in edema
Measured: 14 days
To confirm the performance of the NPWT system in terms of prevention of fixity
Measured: 14 days
To confirm the performance of the NPWT system in terms of prevention of infection
Measured: 14 days
To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
Measured: 14 days
To determine the type (method) of final closure of the open abdomen
Measured: 14 days
To assess the number of days to achieve final closure of the open abdomen
Measured: 14 days
To monitor the length of stay (days) in ICU and length of stay in hospital
Measured: 14 days
To monitor the number and type of re-operations throughout the course of the study
Measured: 14 days
To assess the number of dressing changes
Measured: 14 days
To record clinicians' overall opinion on the usability of the new device throughout the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startDec 2016 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomenal Wound TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime E Dickerson, PhD, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431220
- Sponsor's protocol ID
- 305-001-001-01
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen
- ClinicalTrials.gov ID
- NCT03431220
- Acronym / sponsor ID
- 305-001-001-01
- Conditions
- Abdomenal Wound Trauma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RENASYS TOUCH NPWT System | Experimental | Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) DeviceNegative Pressure Wound Therapy (NPWT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
- Subjects must be at least eighteen (18) yeaTS of age, or older.
- Males and non-pregnant females.
- Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).
Key exclusion criteria (8 listed)
- Grade 3 and Grade 4 open abdomens.
- Malignancy in the reference wound bed or margins of the wound.
- Patients with non-enteric unexplored fistulas.
- High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
- Pre-existing large ventral hernia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) DeviceNPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment. | Device | RENASYS TOUCH NPWT System |
Primary outcome
To determine the number of days taken to achieve delayed primary fascial closure.
Time frame: 14 days
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
12 secondary outcomes
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
Time frame: 14 days
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
Time frame: 14 days
To confirm the performance of the NPWT system in terms of reduction in edema
Time frame: 14 days
To confirm the performance of the NPWT system in terms of prevention of fixity
Time frame: 14 days
To confirm the performance of the NPWT system in terms of prevention of infection
Time frame: 14 days
To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
Time frame: 14 days
To determine the type (method) of final closure of the open abdomen
Time frame: 14 days
To assess the number of days to achieve final closure of the open abdomen
Time frame: 14 days
To monitor the length of stay (days) in ICU and length of stay in hospital
Time frame: 14 days
To monitor the number and type of re-operations throughout the course of the study
Time frame: 14 days
To assess the number of dressing changes
Time frame: 14 days
To record clinicians' overall opinion on the usability of the new device throughout the study
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime E Dickerson, PhD study chair
Smith & Nephew, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device in people with Abdomenal Wound Trauma, run by Smith & Nephew, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the number of days taken to achieve delayed primary fascial closure. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018; AzTrials last refreshed its copy on 26 Oct 2026.